Senior Director, Clinical Pharmacologist - Remote

Overview

The Sr. Director, Clinical Pharmacologist will be responsible for driving translational pharmacokinetic and pharmacodynamic aspects of drug development to support the research and clinical development of orexin agonist(s) programs in various sleep disorders.

In Short

• Lead clinical pharmacology activities for assigned projects.
• Plan and direct clinical pharmacology studies in collaboration with internal and external partners.
• Use PK/PD modeling to support dose selection and safety assessment.
• Oversee clinical pharmacology vendors for accurate PK data collection.
• Apply modeling techniques to optimize study design and data analysis.
• Advise and draft clinical study protocols and regulatory documents.
• Communicate findings to internal and external stakeholders.
• Interface across all disciplines involved in drug development.
• Maintain flexibility in working through virtual and in-person interactions.
• Author scientific publications and present at conferences.

Requirements

• PhD or equivalent in pharmacokinetics, pharmacodynamics, or related discipline.
• Minimum 5 years of pharmaceutical industry experience in clinical pharmacology.
• Strong experience in clinical pharmacology strategies and studies.
• Experience in authoring clinical study protocols and regulatory documents.
• Hands-on experience in PK analysis and regulatory interactions.
• Knowledge of study protocols and PK/PD modeling for sleep disorders.
• Working knowledge of US and EU regulatory requirements.
• Ability to work in a matrix team environment.
• Good interpersonal and communication skills.

Benefits

• Full-Time, Exempt position with flexibility for remote work.